MARC details
| 000 -LIDER |
|---|
| fixed length control field |
05020nam a22005775i 4500 |
| 001 - CONTROL NUMBER |
|---|
| control field |
978-3-031-34567-8 |
| 003 - CONTROL NUMBER IDENTIFIER |
|---|
| control field |
DE-He213 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20240207153550.0 |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION |
|---|
| fixed length control field |
cr nn 008mamaa |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
230801s2023 sz | s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9783031345678 |
| -- |
978-3-031-34567-8 |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER |
|---|
| Classification number |
QH573-671 |
| 072 #7 - SUBJECT CATEGORY CODE |
|---|
| Subject category code |
PSF |
| Source |
bicssc |
| 072 #7 - SUBJECT CATEGORY CODE |
|---|
| Subject category code |
SCI049000 |
| Source |
bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE |
|---|
| Subject category code |
PSF |
| Source |
thema |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Classification number |
571.6 |
| Edition number |
23 |
| 245 10 - TITLE STATEMENT |
|---|
| Title |
Regulatory Aspects of Gene Therapy and Cell Therapy Products |
| Medium |
[electronic resource] : |
| Remainder of title |
A Global Perspective / |
| Statement of responsibility, etc. |
edited by Maria Cristina Galli. |
| 250 ## - EDITION STATEMENT |
|---|
| Edition statement |
2nd ed. 2023. |
| 264 #1 - |
|---|
| -- |
Cham : |
| -- |
Springer International Publishing : |
| -- |
Imprint: Springer, |
| -- |
2023. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
IX, 242 p. 37 illus., 36 illus. in color. |
| Other physical details |
online resource. |
| 336 ## - |
|---|
| -- |
text |
| -- |
txt |
| -- |
rdacontent |
| 337 ## - |
|---|
| -- |
computer |
| -- |
c |
| -- |
rdamedia |
| 338 ## - |
|---|
| -- |
online resource |
| -- |
cr |
| -- |
rdacarrier |
| 347 ## - |
|---|
| -- |
text file |
| -- |
PDF |
| -- |
rda |
| 490 1# - SERIES STATEMENT |
|---|
| Series statement |
Advances in Experimental Medicine and Biology, |
| International Standard Serial Number |
2214-8019 ; |
| Volume/sequential designation |
1430 |
| 500 ## - GENERAL NOTE |
|---|
| General note |
Acceso multiusuario |
| 505 0# - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
Introduction (MCG and FN) -- Updates on ATMP regulations from EU: experience with PRIME procedure and list of approved ATMP -- EU portal for clinical trials application -- European Pharmacopoeia texts on gene therapy medicinal products -- Updates on ATMP regulations from UK after Brexit and list of approved ATMP -- Updates on ATMP regulations from Switzerland and list of approved ATMP -- Updates on ATMP regulations from US FDA: experience with breakthrough/accelerated procedures and list of approved ATMP -- Updates on ATMP regulations from Canada and list of approved ATMP -- Updates on ATMP regulations from Brasil and list of approved ATMP -- Updates on ATMP regulations from Singapore and list of approved ATMP -- Updates on ATMP regulations from Japan: experience with new law and list of approved ATMP -- Updates on ATMP regulations from South Korea and list of approved ATMP -- Updates on ATMP regulations from Taiwan and list of approved ATMP -- Updates on ATMP regulations from Thailand and list of approved ATMP -- ATMP regulations in China and list of approved ATMP -- ATMP regulations in Australia and list of approved ATMP -- ATMP regulations in India and list of approved ATMP -- International harmonization programs. . |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc. |
This book discusses the different regulatory pathways for Advanced Therapy Medicinal Products implemented by national agencies in North and South America, Europe and Asia and by international bodies in the effort of international harmonization. This book represents an update of the first edition, as it covers regulatory novelties and accumulated experience in the regions already addressed. In addition, this new edition offers a wider international perspective: new chapters are included covering Advanced Therapy Medicinal Products regulations in India, Malaysia, Spain and Thailand, the European Pharmacopoeia texts for gene therapy medicinal products as well as international harmonization programs. Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure and therapeutic use of these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of Advanced Therapy Medicinal Products in the areas of product quality, pharmacology and toxicology, clinical trial design and HTA pathways, as well as pertinent 'must-know' guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: a Global Perspective is part of the American Society of Gene & Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals. |
| 541 ## - IMMEDIATE SOURCE OF ACQUISITION NOTE |
|---|
| Owner |
UABC ; |
| Method of acquisition |
Perpetuidad |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Término temático o nombre geográfico como elemento de entrada |
Cytology. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Término temático o nombre geográfico como elemento de entrada |
Medical genetics. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Término temático o nombre geográfico como elemento de entrada |
Genetics. |
| 650 14 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Término temático o nombre geográfico como elemento de entrada |
Cell Biology. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Término temático o nombre geográfico como elemento de entrada |
Medical Genetics. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Término temático o nombre geográfico como elemento de entrada |
Clinical Genetics. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Término temático o nombre geográfico como elemento de entrada |
Genetics. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Galli, Maria Cristina. |
| Relator term |
editor. |
| Relator code |
edt |
| -- |
http://id.loc.gov/vocabulary/relators/edt |
| 710 2# - ADDED ENTRY--CORPORATE NAME |
|---|
| Corporate name or jurisdiction name as entry element |
SpringerLink (Online service) |
| 773 0# - HOST ITEM ENTRY |
|---|
| Title |
Springer Nature eBook |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Relationship information |
Printed edition: |
| International Standard Book Number |
9783031345661 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Relationship information |
Printed edition: |
| International Standard Book Number |
9783031345685 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Relationship information |
Printed edition: |
| International Standard Book Number |
9783031345692 |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE |
|---|
| Uniform title |
Advances in Experimental Medicine and Biology, |
| -- |
2214-8019 ; |
| Volume number/sequential designation |
1430 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Public note |
Libro electrónico |
| Uniform Resource Identifier |
http://libcon.rec.uabc.mx:2048/login?url=https://doi.org/10.1007/978-3-031-34567-8 |
| 912 ## - |
|---|
| -- |
ZDB-2-SBL |
| 912 ## - |
|---|
| -- |
ZDB-2-SXB |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
Libro Electrónico |
